Loteprednol Etabonate Ophthalmic Ointment vs. Vehicle in the Treatment of Inflammation Following Cataract Surgery

Ocular Inflammation Clinical Trial

Official title:

A Randomized Multicenter, Double-Masked, Parallel-Group Clinical Safety and Efficacy Evaluation of Loteprednol Etabonate Ophthalmic Ointment, 0.5% Versus Vehicle for the Treatment of Inflammation Following Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00645671
• Other study ID #: 525
• Status: Completed
• Phase: Phase 3
• First received: March 13, 2008
• Last updated: March 4, 2015
• Start date: March 2008
• Est. completion date: March 2009

Study information

• Verified date: March 2015
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To evaluate the clinical safety and efficacy of Loteprednol Etabonate Ophthalmic Ointment, 0.5% vs. vehicle for the treatment of inflammation following cataract surgery

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subjects who are candidate for routine, uncomplicated cataract surgery

2. Subjects who, in the Investigator's opinion, have potential postoperative pinholed Snellen visual acuity (VA) of at least 20/200 in the study eye.

Exclusion Criteria:

1. Subjects who will require concurrent ocular therapy with NSAIDs, mast cell stabilizers, antihistamines, decongestants, or immunosuppressants (e.g., Restasis), or with ocular or systemic corticosteroids

2. Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components

3. Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye

4. Subjects who have had ocular surgery (including laser surgery) in the study eye within 3 months or in the fellow eye within 2 weeks prior to the Screening Visit

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammation
• Ocular Inflammation

Intervention

Drug:
• 0.5% Loteprednol Etabonate Ophthalmic Ointment
1/2 inch ribbon four times a day for 14 days
• Vehicle of Loteprednol Etabonate Ophthalmic Ointment
1/2 inch ribbon four times a day for 14 days

Locations

Country	Name	City	State
United States	John Hunkeler, MD	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjects With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0.	A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.	Postoperative Day 8 (Visit 5)	No
Primary	Grade 0 for Pain	Pain: A positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. Grade 0 = None; 1=Minimal; 2=Mild; 3=Moderate; 4=Moderately Severe; 5=Severe	Postoperative Day 8 (Visit 5)	No
Secondary	Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit.	A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.	At each follow-up visit through day18 (Visit 7)	No
Secondary	Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare	A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.	Baseline and each follow-up visit through day18 (Visit 7)	No